Trial Outcomes & Findings for Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy (NCT NCT01774305)

Last Updated: 2014-02-10

Results Overview

The coughing incidence and severity will be measured at extubation. Especially from the time of eye opening to 5 min after extubation. The coughing grade was assessed by the following cough grading system: Grade 0, no cough or single, mild cough at extubation; Grade 1, multiple, not sustained cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

141 participants

Primary outcome timeframe

from the time of eye opening to 5 min after extubation

Results posted on

2014-02-10

Participant Flow

recruitment period : Sep.2012. \~ Jan. 2013 types of location : medical clinic.

there was no specific pre-assignment details.

Participant milestones

Participant milestones
Measure	Dexmedetomidine We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.	Saline We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
Overall Study STARTED	71	71
Overall Study COMPLETED	70	71
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Dexmedetomidine We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.	Saline We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
Overall Study Physician Decision	1	0

Baseline Characteristics

Effect of Single-dose Dexmedetomidine on Airway Reflex in Adult With Oral Intubation After Thyroidectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexmedetomidine n=70 Participants We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.	Saline n=71 Participants We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.	Total n=141 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	70 Participants n=5 Participants	71 Participants n=7 Participants	141 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45.3 years STANDARD_DEVIATION 10.4 • n=5 Participants	45.6 years STANDARD_DEVIATION 12.3 • n=7 Participants	45.5 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	53 Participants n=7 Participants	112 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	18 Participants n=7 Participants	29 Participants n=5 Participants
smoking smoking	12 participants n=5 Participants	18 participants n=7 Participants	30 participants n=5 Participants
smoking non-smoking	58 participants n=5 Participants	53 participants n=7 Participants	111 participants n=5 Participants

PRIMARY outcome

Timeframe: from the time of eye opening to 5 min after extubation

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=70 Participants We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.	Saline n=71 Participants We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
Coughing Grade	0.6 units on a scale Standard Deviation 0.9	1.4 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min)

The emergence time will be recorded as the time from sevoflurane discontinuation to eye opening on command.

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=70 Participants We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.	Saline n=71 Participants We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
Emergence Time	492 sec Standard Deviation 176	355 sec Standard Deviation 151

Adverse Events

Dexmedetomidine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dexmedetomidine n=71 participants at risk We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.	Saline n=71 participants at risk We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
Surgical and medical procedures prolonged intubation	1.4% 1/71 • Number of events 1 • 3 hours prolonged intubation more than 3 hrs, due to changed surgical plan.	0.00% 0/71 • 3 hours prolonged intubation more than 3 hrs, due to changed surgical plan.

Additional Information

Dr. Jeongsoo Lee

Yonsei Univ. Health System, Gangnam Severance Hospital

Phone: +82-2-2019-6092

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place